Manager, Regulatory Affairs

Auxilium Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs, for its Malvern, PA location.  This person oversees and directs all regulatory activities.  Will develop and implement regulatory strategies throughout drug development from Phase 1 through Phase 4.  The Regulatory Manager is also responsible to facilitate and work towards the approval of submitted application.

The Major Responsibility Areas for this position include:

· Manage regulatory projects; determine submission requirements and manage all relevant processes by acting as liaison to FDA for Company

· Develop Regulatory stragegy / plans for all drug development, manufacturing and quality programs, in conjunction with development, manufactuirng and quality

· Manage all regulatory application maintenance; IND Annual Reports, NDA Annual and Periodic Reports; Drug Master Files, etc..

· Review advertising for compliance with regulations

· Manage regulatory support activities for non-clinical development, support of clinical development, e.g. protocol reviews, draft product labeling, review of study reports, technical sections of BLA/CTD etc.  .

· Project management, e.g. selection, implementation and maintenance of a regulatory document management system in accordance with 21 CFR Part 11

· Provide regulatory conslutation to other departments i.e. clinical, quality and manufactuirng.  Provide regulatory advice on product compliance, based on solid underatanding of current FDA regulations/guidance's and practices.

· Monitor the effect that proposed changes in FDA regulations may have on current and future developemtn strategies.

 

The Skills and Behaviors of the successful incumbent include:

· Effective communication skills with members of various departments, project team members and senior management

· Able to solve problems innovatively and quickly while considering possible implications of the decisions made.

· Creative and competent when explaining and insturcting/teaching a topic based upon the skill and knowledge level of the receiver

· Ability to prioritize and manage multiple responsibilities simultaneously

· Good judgment/analytical thinking:  ability to differentiate between critical and non-critical issues and to then initiate the appropriate steps.

 

Training and Experience for the successful incumbent include:

· 7 Years industry experience with at least 4 years experience in regulatory affairs, pluys knowledge of FDA regulationd and practices

· Actual work experience (non-regulatory) within the drug developemnt process

· Must have contributed to numerous types of regulatory submissions and demonstrated effective working relationships with the FDA in developing pharmaceutical and biologic products

· Familiarity with CTD and eCTD is desired

· Thorough knowledge of regulations, guidelines, practices and issues within the U.S. pharmaceutical industry.

 

 

Auxilium offers competitive salaries, an outstanding benefits package that includes health and welfare plans, 401(k) with match, flexible spending accounts, employee stock purchase plan, and wellness programs, and a professional and dynamic work environment.

 

Qualified, interested candidates should either use the “apply now” option on this site, or forward their resume, indicating position of interest:

https://home.eease.com/recruit/?id=41242

 

or Fax: 484-321-5997.

 

Auxilium is an equal opportunity employer committed to providing a culturally diverse workplace.